CSV Engineer

Computerized Systems Quality & Validation Specialist | Intermediate

Job Description
A global life sciences organisation is seeking an (Intermediate) Computerized Systems Quality & Validation Specialist to maintain computer systems quality and validation for computerized systems within a GMP-regulated environment.

In this role, you will be responsible for GMP computerized systems administration and validation activities supporting GxP laboratory systems. You will collaborate closely with end users to ensure efficient system usage, regulatory compliance, and adherence to internal quality standards. The position requires strong technical writing capabilities, a solid understanding of cGMP requirements, and the ability to support validation and change management processes in a highly regulated Cell & Gene Therapy environment.

Key responsibilities include administration of GxP lab system software (installation, backup, archival, data management), validation support for new computerized systems (including writing and reviewing validation protocols and reports), troubleshooting system-related issues, supporting deviation and change control processes, auditing systems, and ensuring alignment with internal and external regulatory requirements such as 21 CFR Part 11 and Data Integrity standards.

You will also contribute to system improvement initiatives, collaborate cross-functionally, and support the implementation of new technologies in line with GAMP and validation practices (IQ/OQ/PQ).

Essential Requirements
· Intermediate profile level (no senior profiles)
· Minimum Bachelor’s degree in Science or Technical field
· Experience or exposure to GMP computerized systems administration within a GxP environment
· Knowledge of computerized systems validation, including protocol/report writing and review
· Familiarity with cGMP requirements in clinical and/or commercial manufacturing
· Understanding of 21 CFR Part 11, Data Integrity principles, GAMP, and basic validation practices (IQ/OQ/PQ)
· Good technical writing skills with the ability to document work thoroughly, accurately, and timely
· Ability to troubleshoot system-related issues and support deviation/change control processes
· Strong organizational and time management skills
· Good oral communication skills
· Ability to work effectively and collaboratively within a team environment
· Fluent in English

Preferred Requirements
· Familiarity with Cell & Gene Therapy regulations and cGMP environments
· Experience supporting software implementation and change management activities
· Experience creating design specifications and providing feedback on software setup within regulated environments
· Ability to audit computerized systems and support CAPA implementation
· Proactive mindset with willingness to learn and adapt to new technologies
· Strong collaboration skills and customer-focused mindset
· Ability to balance compliance requirements with operational efficiency
· Demonstrated accountability, reliability, and commitment to quality and safety

Practicalities
Start Date: ASAP
Location: Geleen, NL
Leadership: Individual contributor role
Scope: Site-level GMP computerized systems support

Interested? Send your CV to Miguel Gomes at m.gomes@panda-int.com or call +31 (0)20 2044 502 / +41 (0)44 5514 407 to discuss the opportunity.